Status:
WITHDRAWN
Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)
Lead Sponsor:
4Living Biotech
Conditions:
COVID-19 Acute Respiratory Distress Syndrome
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 ye...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age,
- Using contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Willing and able to provide written informed consent (or provided by legally acceptable representative if he/she is present and if in line with local regulations),
- Admitted in ICU within 48 hours before randomization for COVID-19 related respiratory failure. (ICU or equivalent medical structure according to country specificities e.g., Acute Respiratory Care Unit, High Dependency Care Unit if they can provide: continuous IV infusion,continuous ECG, respiratory rate, percutaneous oxygen saturation screen monitoring, high flow nasal oxygen)
- Not requiring immediate (within 24-36 hours) invasive mechanical ventilation according to investigator's judgment,
- Confirmed pneumoniae due to SARS-CoV-2, Laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR (in nasopharynx or throat samples) or other commercial or public health assay in any specimen, performed within 2 weeks prior to randomization,
- Acute respiratory failure requiring oxygen support (≥ 5L/min) to achieve a transcutaneous oxygen saturation \> 94%,
- Estimated glomerular filtration rate (eGFR) \> 50 mL/min/1.73m2 by the CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) equation.
Exclusion
- Pregnancy or breast feeding,
- Anticipated transfer to another hospital, which is not a study site within 72 hours of randomisation,
- Need for Invasive mechanical ventilation at time of inclusion,
- Evidence of uncontrolled bacterial pneumopathy or active infection other than SARS-Cov-2 (laboratory confirmation),
- Primitive pulmonary arterial hypertension,
- Cardio-vascular co-morbidity:
- History of vascular ischemic events (myocardial infarction or stroke) or congestive heart failure or peripheral arterial disease,
- History or current significant cardiac rhythm disorders (e.g., ventricular tachycardia),
- Known medical history of proven symptomatic postural hypotension,
- Known cancer (solid or blood) in the last 5 previous years or previous haematological disorders (malignancies and other chronic conditions) or having received bone marrow transplant,
- Inadequate haematological function defined by:
- Neutrophil count \< 1.0 x 109/L,
- Haemoglobin \< 9.0 g/dL (90 g/L),
- Platelets \< 100 x 109/L,
- Kaliemia \< 3.5 mmol/L and/or total Calcemia \< 2.2 mmol/L,
- Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) \> 3 x upper limit of normal (ULN) and/or Total bilirubin \> 2 x ULN,
- Patients with known allergy to Plerixafor or its excipients.
- Previous (within 4 weeks) or current participation in another clinical study other than an observational study.
- Patients with auto immune disease treated or not,
Key Trial Info
Start Date :
July 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05411575
Start Date
July 19 2022
End Date
October 1 2022
Last Update
April 10 2023
Active Locations (14)
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1
Multiprofile Hospital for Active Treatment AD Haskovo
Haskovo, Bulgaria, 6300
2
Multiprofile Hospital For Active Treatment Pazardzhik AD
Pazardzhik, Bulgaria, 4400
3
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, Bulgaria, 4002
4
Multiprofile Hospital for Active Treatment Dr Ivan SeliminskiSliven AD
Sliven, Bulgaria, 8800